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临床试验/NCT00373828
NCT00373828已完成不适用

Non-cardiac Chest Pain Evaluation and Treatment Study (CARPA) - Part 1: Diagnosis

Clinical Locomotion Science1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
302
试验地点
1
主要终点
Musculoskeletal chest pain

研究概览

简要总结

The overall aim of the project is to evaluate diagnosis and treatment of chest pain originating from the musculoskeletal system. Specifically, we wish to investigate prevalence and character of such chest pain in a population of patients with acute chest pain, admitted to a university hospital based acute chest pain clinic, and undergoing evaluation of acute coronary syndrome (Part 1). Then, to test a manually-based treatment protocol to patients with diagnosed musculoskeletal chest pain in a randomized clinical trial (Part 2).

The specific purpose of this study (Part 1) is to determine the exact number of patients with acute chest pain origination from the musculoskeletal system, and to describe their cardiac status with respect to ischemic heart disease. Further, we wish to evaluate the decision making process of the chiropractor.

详细描述

Acute chest pain is a common reason for hospital admission. The focus of diagnosis is of course pain of cardiac origin including myocardial infarction and/or other ischemic heart disease; however, in up to 50% of cases the aetiology may be non-cardiac. Differential diagnoses include primarily pulmonary, gastrointestinal, psychosocial, or musculoskeletal problems, and musculoskeletal problems may account for around 20% of the total number of admissions in acute chest pain clinics. Thus the musculoskeletal system is a recognized possible source of pain in patients with chest pain even though a confident diagnosis of musculoskeletal chest pain can be difficult to establish since no gold standard exists to verify this diagnosis.

Chest pain patients with normal coronary anatomy have an excellent prognosis for survival and a future risk of cardiac morbidity similar to that reported in the background population. However, about three quarters of patients with non-cardiac chest pain continue to suffer from residual chest pain with large socio-economic consequences. Therefore, a search for an alternative cause with related possibilities for treatment is warranted. Given these perspectives, the general objective of the present work is to study the diagnosis of chest pain originating from the musculoskeletal system of the cervical and thoracic spine, and thorax in patients with chest pain of various origins, and to evaluate ischemic heart disease status among patients with presumed musculoskeletal pain.

Evaluation:

Patients with musculoskeletal chest pain will be identified using a standardized examination protocol comprised of a semi-structured interview, a general health examination, and a specific manual examination of the muscles and joints of the neck, thoracic spine and thorax. All patients will have a Myocardial Perfusion Imaging (MPI) performed and results from the MPI will be compared with the musculoskeletal status. Specific important parameters of the standardized examination protocol will be identified and the decision making process of the chiropractor will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic.
  • Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG.
  • Pain arising from the thorax and/or neck.
  • Able to read and understand Danish.

排除标准

  • Acute coronary syndrome.
  • Percutaneous Coronary Intervention.
  • Coronary Artery Bypass Grafting.
  • Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain.
  • No written consent.
  • Inflammatory joint disease.
  • Diabetes mellitus, type I.
  • Fibromyalgia.
  • Sharp trauma to the chest.
  • Malignant disease.
  • Apoplexy.
  • Gross osseous anomalies, such as pronounced scoliosis.
  • Known or suspected osteoporosis.
  • Pregnancy.
  • Dementia/unable to cooperate.
  • Not residing in the County of Funen.
  • Does not want to participate.
  • Other - reason for exclusion will be noted.

结局指标

主要结局

Musculoskeletal chest pain

时间窗: baseline

Presence of MSCP yes/no

次要结局

未报告次要终点

研究者

发起方
Clinical Locomotion Science
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Jensen Stochkendahl

DC, PhD

Clinical Locomotion Science

研究点 (1)

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